Application 209446
- Type
- ANDA
- Sponsor
- SAWAI USA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MIRABEGRON | MIRABEGRON | TABLET, EXTENDED RELEASE;ORAL | 25MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A209446-001 | MIRABEGRON | MIRABEGRON | 25MG | TABLET, EXTENDED RELEASE / ORAL | 2019-12-27 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A209446-001 | MIRABEGRON | 25MG | TABLET, EXTENDED RELEASE / ORAL | 2019-12-27 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209446-001 | MIRABEGRON | 25MG | TABLET, EXTENDED RELEASE / ORAL | 2019-12-27 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A209446-001 | MIRABEGRON | 25MG | TABLET, EXTENDED RELEASE / ORAL | 2019-12-27 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209446-001 | MIRABEGRON | 25MG | TABLET, EXTENDED RELEASE / ORAL | 2019-12-27 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209446-001 | MIRABEGRON | 25MG | TABLET, EXTENDED RELEASE / ORAL | 2019-12-27 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209446-001 | MIRABEGRON | 25MG | TABLET, EXTENDED RELEASE / ORAL | 2019-12-27 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209446-001 | MIRABEGRON | 25MG | TABLET, EXTENDED RELEASE / ORAL | 2019-12-27 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209446-001 | MIRABEGRON | 25MG | TABLET, EXTENDED RELEASE / ORAL | 2019-12-27 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209446-001 | MIRABEGRON | 25MG | TABLET, EXTENDED RELEASE / ORAL | 2019-12-27 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A209446-001 | MIRABEGRON | 25MG | TABLET, EXTENDED RELEASE / ORAL | 2019-12-27 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209446-001 | MIRABEGRON | 25MG | TABLET, EXTENDED RELEASE / ORAL | 2019-12-27 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209446-001 | MIRABEGRON | 25MG | TABLET, EXTENDED RELEASE / ORAL | 2019-12-27 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209446-001 | MIRABEGRON | 25MG | TABLET, EXTENDED RELEASE / ORAL | 2019-12-27 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A209446-001 | MIRABEGRON | 25MG | TABLET, EXTENDED RELEASE / ORAL | 2019-12-27 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A209446-001 | MIRABEGRON | 25MG | TABLET, EXTENDED RELEASE / ORAL | 2019-12-27 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A209446-001 | MIRABEGRON | 25MG | TABLET, EXTENDED RELEASE / ORAL | 2019-12-27 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A209446-001 | MIRABEGRON | 25MG | TABLET, EXTENDED RELEASE / ORAL | 2019-12-27 | 4b0b4de00fa7… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A209446-001 | MIRABEGRON | 25MG | TABLET, EXTENDED RELEASE / ORAL | 2019-12-27 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A209446-001 | MIRABEGRON | 25MG | TABLET, EXTENDED RELEASE / ORAL | 2019-12-27 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A209446-001 | MIRABEGRON | 25MG | TABLET, EXTENDED RELEASE / ORAL | 2019-12-27 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A209446-001 | MIRABEGRON | 25MG | TABLET, EXTENDED RELEASE / ORAL | 2019-12-27 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A209446-001 | MIRABEGRON | 25MG | TABLET, EXTENDED RELEASE / ORAL | 2019-12-27 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A209446-001 | MIRABEGRON | 25MG | TABLET, EXTENDED RELEASE / ORAL | 2019-12-27 | c0c555d07b60… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A209446-001 | MIRABEGRON | 25MG | TABLET, EXTENDED RELEASE / ORAL | 2019-12-27 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A209446-001 | MIRABEGRON | 25MG | TABLET, EXTENDED RELEASE / ORAL | 2019-12-27 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A209446-001 | MIRABEGRON | 25MG | TABLET, EXTENDED RELEASE / ORAL | 2019-12-27 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A209446-001 | MIRABEGRON | 25MG | TABLET, EXTENDED RELEASE / ORAL | 2019-12-27 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A209446-001 | MIRABEGRON | 25MG | TABLET, EXTENDED RELEASE / ORAL | 2019-12-27 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A209446-001 | MIRABEGRON | 25MG | TABLET, EXTENDED RELEASE / ORAL | 2019-12-27 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A209446-001 | MIRABEGRON | 25MG | TABLET, EXTENDED RELEASE / ORAL | 2019-12-27 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A209446-001 | MIRABEGRON | 25MG | TABLET, EXTENDED RELEASE / ORAL | 2019-12-27 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A209446-001 | MIRABEGRON | 25MG | TABLET, EXTENDED RELEASE / ORAL | 2019-12-27 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A209446-001 | MIRABEGRON | 25MG | TABLET, EXTENDED RELEASE / ORAL | 2019-12-27 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A209446-001 | MIRABEGRON | 25MG | TABLET, EXTENDED RELEASE / ORAL | 2019-12-27 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A209446-001 | MIRABEGRON | 25MG | TABLET, EXTENDED RELEASE / ORAL | 2019-12-27 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A209446-001 | MIRABEGRON | 25MG | TABLET, EXTENDED RELEASE / ORAL | 2019-12-27 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A209446-001 | MIRABEGRON | 25MG | TABLET, EXTENDED RELEASE / ORAL | 2019-12-27 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| MIRABEGRON | MIRABEGRON | REMEDYREPACK INC. | d0054db9-e38a-4786-be2c-996fa5b8f47d | 2026-05-22 | Warnings, Adverse reactions | MIRABEGRON MIRABEGRON |
| Mirabegron | MIRABEGRON | Ascend Laboratories, LLC | 1c9022af-4841-4f3f-9737-1c5eef58e86b | 2026-05-22 | Warnings, Adverse reactions | Mirabegron MIRABEGRON |
| Mirabegron | MIRABEGRON | REMEDYREPACK INC. | b71b939e-8cb1-492c-8311-28f75dc4c682 | 2026-04-27 | Warnings, Adverse reactions | Mirabegron MIRABEGRON |
| Mirabegron | MIRABEGRON | Amneal Pharmaceuticals NY LLC | e597023d-6dcc-4d9e-8ce0-2d28a5d862f3 | 2026-03-26 | Warnings, Adverse reactions | Mirabegron MIRABEGRON |
| MIRABEGRON | MIRABEGRON | Lupin Pharmaceuticals, Inc. | d22d3d12-8466-46db-bc19-d13e87c6115c | 2025-12-24 | Warnings, Adverse reactions | MIRABEGRON MIRABEGRON |
| Mirabegron | MIRABEGRON | Qilu Pharmaceutical Co., Ltd. | 98247602-29b9-4621-8eeb-519e40b883b9 | 2025-10-21 | Warnings, Adverse reactions | Mirabegron MIRABEGRON |
| Mirabegron | MIRABEGRON | REMEDYREPACK INC. | 5f7a1758-8691-4e53-96d6-a01626ee8140 | 2025-10-02 | Warnings, Adverse reactions | Mirabegron MIRABEGRON |
| MIRABEGRON | MIRABEGRON | Bryant Ranch Prepack | 00826723-d25e-498a-b8d4-d17e5c14dda5 | 2025-09-26 | Warnings, Adverse reactions | MIRABEGRON MIRABEGRON |
| MIRABEGRON | MIRABEGRON | Bryant Ranch Prepack | 1a7337a4-2901-4e65-b666-7623fadb78f2 | 2025-09-26 | Warnings, Adverse reactions | MIRABEGRON MIRABEGRON |
| MIRABEGRON | MIRABEGRON | Bryant Ranch Prepack | 2965e083-b678-43b9-8e13-2efddc0daad0 | 2025-09-26 | Warnings, Adverse reactions | MIRABEGRON MIRABEGRON |
| MIRABEGRON | MIRABEGRON | Bryant Ranch Prepack | 3bd73250-2b31-4b22-983b-15119846e697 | 2025-09-26 | Warnings, Adverse reactions | MIRABEGRON MIRABEGRON |
| Mirabegron | MIRABEGRON | Zydus Lifesciences Limited | 461b2b94-205a-4860-9cb4-d30267ada9df | 2024-10-09 | Warnings, Adverse reactions | Mirabegron MIRABEGRON |
| Mirabegron | MIRABEGRON | Zydus Pharmaceuticals (USA) Inc. | 2e40eb74-3b2a-47f7-bf31-fe27484f9bd2 | 2024-10-09 | Warnings, Adverse reactions | Mirabegron MIRABEGRON |
| Myrbetriq | MIRABEGRON | Astellas Pharma US, Inc. | ba9e9e15-e666-4c56-9271-2e24739cfa2d | 2024-08-01 | Warnings, Adverse reactions | MIRABEGRON |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 55973 | ORIG | 2020-03-17 |